Balloninflation After Evacuation of Chronical Subdural Haematoma for Reduction of Hematoma Recurrrence: Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Recurrence Rate
研究概览
简要总结
In this prospective, randomized, multicenter trial shall patients with chronic subdural hematoma (cSDH) recruited, who were surgically treated. Initially, we would divide the patients randomized into two groups: Patients with supervised blow-maneuver and without. After surgical treatment of cSDH with insertion of a subdural drain, one group would perform a supervised blow maneuver ("Valsalva maneuver") every hour for five minutes from 10:00 to 20:00. In the other group, the standard care would be performed. The subdural drain would be explanted 2days after operation and a postoperative CT scan would routinely be performed. After hospital discharge, the patient would be rechecked in an ambulant setting and would receive CT scan as clinical standard. Recurrence of hematoma is defined as recurrent hematoma which should be reoperated. After 3 and 6 months we would evaluate the outcome of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age over 18 years
- •surgically treated cSDH
- •patients with an operatively implanted subdural drainage
排除标准
- •age under 18 years
- •Admission in critical clinical state, e.g. already to light unresponsive pupils for about 2 hours
- •conservative treatment of cSDH
- •patients without an operatively implanted subdural drainage
- •patient cannot be consented
- •participation in other clinical trials
结局指标
主要结局
Recurrence Rate
时间窗: 3 Months
Reoperation of chronic subdural hematoma
次要结局
- Neurological Functional Outcome(6 Months)
研究者
Marina Heibel
Study Nurse
Johann Wolfgang Goethe University Hospital
